A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2202 or Co-administration of RLD2202 and RLD2203 in Healthy Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548387
• Other study ID #: HM-SARA-102
• Status: Completed
• Phase: Phase 1
• Start date: September 2, 2022
• Est. completion date: November 10, 2022

Study information

• Verified date: September 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fasting condition in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 54 Years

Eligibility

Inclusion Criteria:

• Age 19~54 years in healthy volunteers 18.5 kg/m^2 = BMI < 30 kg/m^2, weight(men) =55kg / weight(women) =45kg

• 90 mmHg = SBP <140 mmHg, 50 mmHg = DBP <90 mmHg

• agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

• Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system

• Subjects who judged ineligible by the investigator

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HCP2202
Take it once per period.
• RLD2202
Take it once per period.
• RLD2203
Take it once per period.

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Pharmacokinetic evaluation	0~24 hours
Primary	Cmax	Pharmacokinetic evaluation	0~24 hours
Secondary	AUCinf	Pharmacokinetic evaluation	0~24 hours
Secondary	Tmax	Pharmacokinetic evaluation	0~24 hours
Secondary	t1/2	Pharmacokinetic evaluation	0~24 hours
Secondary	CL/F	Pharmacokinetic evaluation	0~24 hours
Secondary	Vd/F	Pharmacokinetic evaluation	0~24 hours